CORONA, Calif., Aug. 13 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals,
Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today
that the United States District Court for the Southern District of Florida
ruled today that Watson's Naproxen Sodium ER tablets, the generic version of
Naprelan(R), infringes Elan's U.S. Patent No. 5,637,320 (the "'320 Patent").
The action, Elan Corporation Plc v. Andrx Pharmaceuticals, Inc., was initially
brought by Elan in October 1998 following Andrx's filing of a paragraph IV
Abbreviated New Drug Application for its product. In March 2002, the District
Court ruled that Elan's '320 Patent was invalid. Subsequently, in May 2004,
the United States Court of Appeals for the Federal Circuit reversed the
District Court's finding of invalidity and remanded the case for further
proceedings. In January 2005, Elan filed a related case against Andrx in the
United States District Court for the Southern District of Florida alleging
that Andrx's Naproxen Sodium ER tablets infringe the '320 Patent, and seeking
damages for willful infringement. In late 2005 the parties completed briefing
the District Court on the validity of the '320 Patent and whether Andrx's
product infringes the '320 Patent. The matter has been under submission to
the District Court since late 2005. In today's ruling, the District Court
held that Andrx's Naproxen Sodium ER tablets infringe the '320 Patent and that
Andrx's infringement was willful. The District Court has set a further
hearing on the matter for September 19, 2008, to address issues related to a
damages phase of the trial and the possibility of injunctive relief. The
Company intends to appeal today's ruling.
"We are disappointed and disagree with the court's ruling today and
believe we have substantial meritorious issues to raise on appeal," stated
Paul M. Bisaro, Watson's President and Chief Executive Officer. "We will
continue to vigorously defend our position that our product does not infringe
the '320 Patent," concluded Mr. Bisaro. Andrx launched its 500 mg Naproxen
Sodium ER tablets in September 2002. For the twelve months ended December 31,
2001, Elan's 500 mg Naprelan(R) product had sales of approximately $27
million, according to IMS Health Data. For the twelve months ending June 30,
2008, Watson's 500 mg Naproxen Sodium ER tablets had sales of approximately $4
million, according to IMS Health Data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading
specialty pharmaceutical company that develops, manufactures, markets, sells
and distributes brand and generic pharmaceutical products. Watson pursues a
growth strategy combining internal product development, strategic alliances
and collaborations and synergistic acquisitions of products and businesses.
For press releases and other company information, visit Watson
Pharmaceuticals' Web site at http://www.watson.com.
Forward-Looking Statement
Any statements contained in this press release that refer to future events
or other non-historical facts are forward-looking statements that reflect
Watson's current perspective of existing trends and information as of the date
of this release. These forward looking statements include, but are not
limited to, statements concerning the potential of being successful in the
appeal of today's District Court ruling concerning the '320 Patent. Except as
expressly required by law, Watson disclaims any intent or obligation to update
these forward-looking statements. Actual results may differ materially from
Watson's current expectations depending upon a number of factors affecting
Watson's business. These factors include, among others, the difficulty of
predicting the timing or outcome of litigation, including the appeal of
today's District Court ruling concerning the '320 Patent; the inherent
uncertainty of litigation; the potentially material adverse effects on the
Company's results of operations, financial condition and cash flows of a final
decision that the Company infringes the '320 Patent; market acceptance of and
continued demand for Watson's products; patents and other intellectual
property rights held by competitors and other third parties; and other risks
and uncertainties detailed in Watson's periodic public filings with the
Securities and Exchange Commission, including but not limited to Watson's
Annual Report on Form 10-K for the year ended December 31, 2007.
Naprelan(R) is a registered trademark of Elan Corporation plc.
(Logo: http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO)
SOURCE Watson Pharmaceuticals, Inc.
Investor Relations, Patty Eisenhaur of Watson Pharmaceuticals, Inc.,
+1-951-493-5611
